The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions

NCT05547932 | Completed

• 1 other identifier: MSK8/22
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.

Conditions

Breast Cancer; Postoperative Pain; Respiratory Function Impaired

Keywords

Analgesia; postoperative pain; rhomboid intercostal block; serratus anterior plane block; respiratory function

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 second (FEV1)

  FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

  postoperative 2nd hour

Secondary Outcomes (6)

• Postoperative pain

  Postoperative second hour

• Postoperative opioid consumption

  Postoperative 24th hour

• Forced Vital Capacity (FVC)

  postoperative 2nd hour

• FEV1/FVC

  postoperative 2nd hour

• forced expiratory flow at 25-75% of forced vital capacity (FEF25-75)

  postoperative 2nd hour

Study Arms (2)

Block Group

EXPERIMENTAL

After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 20 ml of bupivacaine 0.25%. In the same position, the probe will be placed at the midaxillary line at the level of T3, and the landmark points (latissimus dorsi muscle and serratus muscle and intercostal muscles) will be observed. Under sterile conditions, a SAP block will be performed by injecting 20 ml of Bupivacaine 0.25% into the plane between serratus muscle and intercostal muscle.

Procedure: RIB+SAP blocks

Control Group

NO INTERVENTION

No block procedures will be performed in this group.

Interventions

RIB+SAP blocks PROCEDURE

RIB block will be performed after endotracheal intubation, then a SAP block will be performed. No other intervention will be performed to the patients.

Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients
• Female
• Ages between 18-65
• Patients who will receive breast cancer surgery under general anesthesia

You may not qualify if:

• Known respiratory diseases
• Rhinitis and atopic dermatitis story
• New York Heart Association Class equal to higher than class 2
• Respiratory diseases story in the last two weeks
• Alchol or substance or chronic opioid consumption story
• Any pain killers intake in the last 24 hours prior to surgery
• Active smokers or ex-smokers
• Body mass index over 35 kg/m2
• İnfection at the injection sites
• Known allergy to local anesthetics
• Known psychiatric diseases
• Operations longer than 3 hours

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Sıtkı Koçman University

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Respiratory Insufficiency; Agnosia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Bakiye Uğur, MD

  Muğla Sıtkı Koçman University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients will be under general anesthesia and will not know if they received a block procedure or not. The investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof Dr

Model Details: Prospective, randomized, controlled study

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: September 21, 2022
• Study Start: September 21, 2022
• Primary Completion: April 13, 2023
• Study Completion: April 14, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)